R01AG068141

The Trajectories and Clinical Experiences of ICD Therapy (TRACER-ICD) study - project summary / abstract x

Over 50,000 implantable cardioverter-defibrillators (ICDs) are implanted annually in patients =65 years old at an estimated cost of >$2 billion. ICD guidelines draw upon trials enrolling few older patients, yet half of these patients will either be dead or enrolled in hospice within 5 years of implantation.

Though Medicare now mandates shared decision-making (SDM) for ICDs, few studies have investigated questions vital for older patients, including health status trajectories and quality of life. Improved SDM for older patients requires moving beyond average treatment effect estimates to incorporate precision modeling of these outcomes. There is therefore a pressing need for longitudinal data to support patient-centered SDM for older adults.

To extend our prior work and further improve SDM for older adults considering an ICD, we propose the Trajectories and Clinical Experiences of ICD Therapy (TRACER-ICD) study, a multi-center prospective cohort with the goal of better defining patient-centered goals and experiences in older patients undergoing ICD implantation. We will prospectively collect data on geriatric conditions and quality of life from patients at 5 sites, enriched with remote monitoring data on arrhythmias and physical activity, to evaluate their clinical and functional trajectories (AIM 1).

This cohort will support further refinement of our statistical model to personalize prediction of treatment outcomes (AIM 2). Lastly, we will use mixed methods to identify optimal implementation strategies for translating these individualized prediction profiles into SDM for ICDs (AIM 3).

This proposal is led by an early stage investigator whose expertise in cardiac electrophysiology, geriatric medicine, and outcomes research will be complemented by an experienced research team with a strong record of collaboration.

Impact: As the first comprehensive, prospective study of older ICD patients, TRACER-ICD will generate unique patient-centered and personalized data essential for characterizing outcomes of this common procedure in a vulnerable population. Much like other large cohort studies in older persons, we anticipate the robust data emerging from TRACER-ICD will serve as a rich resource that will improve care for millions of patients considering ICD implantation, and provide essential, evidence-based guidance for translating personalized outcome profiling into the SDM experience.

Beth Israel Deaconess Medical Center

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Boston, Massachusetts 022155400 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Amendment Since initial award the total obligations have increased 383% from $712,025 to $3,439,497.